Stent delivery system and method of use

ABSTRACT

A balloon dilation catheter comprising: a tubular member having a proximal end and a distal end and an inflatable balloon disposed at the distal end of the tubular member. The tubular member comprises a first lumen disposed in communication with an interior of the inflatable balloon and a second lumen for receiving a guidewire substantially along the entire length of the tubular member. The second lumen has a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member. A first slit is disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen. The subject balloon dilation catheter provides improved rapid exchange advantages of either the catheter or the guidewire used in a catheterization technique.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] In one of its aspects, the present invention relates to a balloon dilation catheter. In another of its aspects, the present invention relates to a catheterization method.

[0003] 2. Brief Description of the Prior Art

[0004] Balloon dilation catheters have been known for many years. Originally, such catheters were used in interventional techniques such as angioplasty.

[0005] In recent years, balloon dilation catheters have also been used to facilitate endovascular prosthesis' such as stents. Stents are generally known. Indeed, the term “stent” has been used interchangeably with terms such as “intraluminal vascular graft” and “expansible prosthesis”. As used throughout this specification, the term “stent” is intended to have a broad meaning and encompasses any expandable prosthetic device for implantation in a body passageway (e.g., a lumen or artery).

[0006] In the past dozen years, the use of stents has attracted an increasing amount of attention due to the potential of these devices to be used, in certain cases, as an alternative to surgery. Generally, a stent is used to obtain and maintain the patency of the body passageway while maintaining the integrity of the passageway. As used in this specification, the term “body passageway” is intended to have a broad meaning and encompasses any duct (e.g., natural or iatrogenic) within the human body and can include a member selected from the group comprising: blood vessels, respiratory ducts, gastrointestinal ducts and the like.

[0007] Stent development has evolved to the point where the vast majority of currently available stents rely on controlled plastic deformation of the entire structure of the stent at the target body passageway so that only sufficient force to maintain the patency of the body passageway is applied during expansion of the stent.

[0008] Generally, in many ofthese systems, a stent, in association with a balloon, is delivered to the target area of the body passageway by a catheter system. Once the stent has been properly located (for example, for intravascular implantation the target area of the vessel can be filled with a contrast medium to facilitate visualization during fluoroscopy), the balloon is expanded thereby plastically deforming the entire structure of the stent so that the latter is urged in place against the body passageway. As indicated above, the amount of force applied is at least that necessary to expand the stent (i.e., the applied force exceeds the minimum force above which the stent material will undergo plastic deformation) while maintaining the patency of the body passageway. At this point, the balloon is deflated and withdrawn within the catheter, and is subsequently removed. Ideally, the stent will remain in place and maintain the target area of the body passageway substantially free of blockage (or narrowing).

[0009] See, for example, any of the following patents:

[0010] U.S. Pat. No. 4,323,071 (Simpson et al.),

[0011] U.S. Pat. No. 4,411,055 (Simpson et al.),

[0012] U.S. Pat. No. 4,616,648 (Simpson),

[0013] U.S. Pat. No. 4,661,094 (Simpson),

[0014] U.S. Pat. No. 4,733,665 (Palmaz),

[0015] U.S. Pat. No. 4,739,762 (Palmaz),

[0016] U.S. Pat. No. 4,800,882 (Gianturco),

[0017] U.S. Pat. No. 4,907,336 (Gianturco),

[0018] U.S. Pat. No. 5,035,706 (Gianturco et al.),

[0019] U.S. Pat. No. 5,037,392 (Hillstead),

[0020] U.S. Pat. No. 5,041,126 (Gianturco),

[0021] U.S. Pat. No. 5,092,873 (Simpson et al.),

[0022] U.S. Pat. No. 5,102,417 (Palmaz),

[0023] U.S. Pat. No. 5,147,385 (Beck et al.),

[0024] U.S. Pat. No. 5,269,793 (Simpson),

[0025] U.S. Pat. No. 5,282,824 (Gianturco),

[0026] U.S. Pat. No. 5,316,023 (Palmaz et al.),

[0027] U.S. Pat. No. 5,415,634 (Glynn et al.),

[0028] U.S. Pat. No. 5,462,529 (Simpson et al.),

[0029] U.S. Pat. No. 5,755,771 (Penn et al.),

[0030] U.S. Pat. No. 5,980,570 (Simpson),

[0031] International patent application PCT/CA97/00151 (Penn et al.), and

[0032] International patent application PCT/CA97/00152 (Penn et al.),

[0033] for a discussion on previous stent designs and deployment systems.

[0034] Given the development of stent design, the prior art has also focussed on delivery systems for stent deployment.

[0035] One particular delivery system is taught by U.S. Pat. No. 4,748,982 [Horzewski et al. (Horzewski)]. Horzewski teaches a reinforced balloon dilation catheter with a slitted exchange sleeve. Essentially, the catheter comprises a tubular member having a first lumen and a second lumen. A dilation balloon is mounted on the distal end of the tubular member and is in communication with the first lumen. An opening (or notch) is disposed in the tubular member intermediate its proximal and distal ends for receiving a guidewire which travels through the second lumen and emanates out of the distal end of the tubular member. A slit is disposed on the longitudinal portion of the tubular member between the opening and an area 0.5-1 cm proximal the dilation balloon. Thus, as illustrated in FIG. 1 of Horzewski, the guidewire travels partly within a lumen in the catheter (approximately 10-15 cm) and partly along the outside of the catheter (approximately 80-90 cm ). This approach is also known as a “monorail” delivery system. The principal advantage of this approach is that it permits so-called “rapid exchange” of the balloon catheter with another balloon catheter. In design, the exchange is facilitated by the provision of the above-mentioned slit so that the actual exchange is done over the balloon portion only (approximately 3 cm ). The principal disadvantages of this approach include: less than optimum steerability of the guidewire, difficulties in moving the guidewire with respect to the catheter, less than optimum torque control and inability to exchange the guidewire while leaving the catheter in place. The catheter illustrated by Horzewski has not gained widespread commercial popularity.

[0036] Another approach for catheterization is the so-called “over the wire” approach—this approach is discussed in many of the above-mentioned United States patents naming John P. Simpson as an inventor. In this approach, the catheter comprises a tubular member having a first lumen and a second lumen. A dilation balloon is mounted on the distal end of the tubular member and is in communication with the first lumen. The second lumen runs through the length of the tubular member. An opening is disposed in the tubular member at its proximal end for receiving a guidewire which travels through second lumen and emanates out of the distal end of the tubular member. Thus, in the “over the wire” approach, the guidewire is enpassed by the second lumen along the entire length of the tubular member (approximately 90-105 cm). The principal advantages of the this approach include: optimum steerability, smoother movement of the guidewire with respect to the catheter (due to the coaxial relationship thereof), optimum torque control and the ability to exchange the guidewire while leaving the catheter in place. The principal is disadvantage of this approach is that exchange with another balloon catheter is relatively cumbersome (i.e., compared to the “monorail” approach discussed above.

[0037] Accordingly, it would be desirable to have a balloon dilation catheter which combined the advantages of the above-mentioned “monorail” approach and “over the wire” approach while obviating or mitigating the disadvantages of these approaches. It would be further advantageous if the balloon dilation catheter were readily adaptable to be used in various interventional techniques such as endovascular prosthesis delivery, angioplasty and the like.

SUMMARY OF THE INVENTION

[0038] It is an object of the present invention to provide a novel balloon dilation catheter.

[0039] It is another object of the present invention to provide a novel catheterization method.

[0040] Accordingly, in one of its aspects, the present invention provides a balloon dilation catheter comprising:

[0041] a tubular member having a proximal end and a distal end;

[0042] an inflatable balloon disposed at the distal end of the tubular member;

[0043] a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon;

[0044] a second lumen disposed in the tubular member for receiving a guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and

[0045] a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.

[0046] In another of its aspects, the present invention provides a catheterization kit comprising:

[0047] a guide catheter;

[0048] a guide wire; and

[0049] a balloon dilation catheter comprising: a tubular member having a proximal end and a distal end; an inflatable balloon disposed at the distal end of the tubular member;

[0050] a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon; a second lumen disposed in the tubular member for receiving the guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.

[0051] In yet another of its aspects, the present invention provides a stent-mounted balloon catheter comprising:

[0052] a tubular member having a proximal end and a distal end;

[0053] an inflatable balloon disposed at the distal end of the tubular member;

[0054] a stent mounted on the inflatable balloon;

[0055] a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon;

[0056] a second lumen disposed in the tubular member for receiving a guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and

[0057] a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.

[0058] Thus, the present inventors have discovered a balloon catheter which combines the advantages of the “over the wire” approach (i.e., optimum steerability, smoother movement of the guidewire with respect to the catheter (due to the coaxial relationship thereof), optimum torque control and the ability to exchange the guidewire while leaving the catheter in place) with the principal advantage of the “monorail” approach (i.e., rapid exchange of the balloon catheter with another balloon catheter while leaving the guidewire in place).

[0059] As used throughout this specification, the term “tubular member”, when used in the context of the present balloon dilation catheter is intended to mean a portion of the catheter generally tubular in construction and generally representing the large majority of the overall length of the balloon dilation catheter. Typically, the tubular member will be at least about 75%, more preferably at least about 85%, most preferably at least about 95%, of the overall length of the balloon dilation catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Embodiments of the present invention will be described with reference to the accompanying drawings wherein like numerals designate like parts and in which:

[0061]FIG. 1 illustrates a perspective view of an embodiment of the present balloon dilation catheter;

[0062]FIG. 2 is a sectional view along line II-II in FIG. 1;

[0063]FIG. 3 is a sectional view along line III-III in FIG. 1;

[0064]FIG. 4 illustrates an exploded view of modified proximal end of the balloon dilation catheter illustrated in FIG. 1;

[0065] FIGS. 5-11 illustrate steps in various catheterization techniques employing the present balloon dilation catheter;

[0066]FIG. 12 illustrates a modified balloon for use in the present balloon dilation catheter; and

[0067]FIG. 13 illustrates a preferred embodiment of a modified tubular member for use in the present balloon dilation catheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] Thus, with reference to FIGS. 1-3, there is illustrated a balloon dilation catheter 100. Balloon dilation catheter 100 comprises a proximal end 105 and a distal end 110. Distal end 110 of balloon dilation catheter 100 comprises an expandable balloon 115. Proximal end 105 of balloon dilation catheter 100 comprises an single lumen Luer-type adaptor 120. Disposed between adaptor 120 and balloon 115 is a tubular member 125.

[0069] As will be apparent from FIG. 1, disposed in tubular member 125 is an opening 130. Also disposed in tubular member 125 is a slit 135 which extends from opening 130 to a point in tubular member 125 just proximal balloon 115.

[0070] With particular reference to FIGS. 2 and 3, tubular member 125 comprises a first lumen 140 and a second lumen 150. First lumen 140 is designed to be in communication with an interior of balloon 115. The design of the interface between balloon 115 and first lumen 140 is conventional—see for example Horzewski referred to hereinabove. The construction of tubular member 125 having opening 130, slit 135, first lumen 140 and second lumen 150 is conventional—see Horzewski referred to hereinabove.

[0071] With further reference to FIGS. 1-3, it will be apparent that opening 130 is designed to receive a guidewire 160. Guidewire 160 passes through second lumen 150 and out of a distal opening of tubular member 125 beyond balloon 115.

[0072] In FIG. 4, there is illustrated a modification of balloon dilation catheter 100 illustrated in FIGS. 1-3.

[0073] Specifically, in FIG. 4, Luer-type adaptor 120 a is modified to contain a lumen 150 a in communication with a slit 135 a. As will be apparent to those of skill in the art, lumen 150 a is in communication with second lumen 150 in tubular member 125. Further, slit 135 a is in communication with slit 135 in tubular member 125. The modification of balloon dilation catheter 100 illustrated in FIG. 4 eliminates the need for having opening 130 disposed in tubular member 125 illustrated in FIG. 1.

[0074] With reference to FIGS. 5-9, the delivery of balloon dilation catheter 100 will be described.

[0075] As is known in the art, catheterization is normally performed to alleviate a lesion in an artery. This is shown schematically in FIGS. 6-9 wherein a lesion in the form of a blockage 15 obstructs an artery 20. In certain cases, it is desirable to deploy a stent at the site of the lesion to maintain the patency of artery 20 at the site of blockage 15. As shown in FIG. 5, catheterization is performed through an incision in the groin area of the patient.

[0076] Thus, with reference to FIGS. 6 and 7, a guide catheter 25 is initially delivered into artery 20 to a region proximal of blockage 15. The proximal end of guide catheter 25 remains outside the patient.

[0077] Balloon dilation catheter 100 (FIG. 1) has mounted on balloon 115 thereof a stent 30. Further, guidewire 160 in second lumen 150 such that it emanates from opening 130 and from distal end 110 of balloon dilation catheter 100. Preferably, this is achieved in a conventional manner by feeding guidewire 160 into second lumen 150 at distal end 110 of balloon dilation catheter 100 until the proximal end of guidewire 160 emanates from opening 130.

[0078] At this point, balloon dilation catheter 100 is inserted into guide catheter 25 and guidewire 160 is navigated through artery 20 to a point distally of blockage 15 (FIG. 7).

[0079] Aternatively, it is possible to advance guidewire 160 to a point distally of blockage 15, after which the distal end of second lumen 150 of balloon dilation catheter 100 is passed onto the proximal end of guidewire 160. If it becomes difficult to advance guidewire 160 across blockage 15 using this technique, it is possible to advance balloon dilation catheter over the proximal end of guidewire 160 until that end exits opening 130 and the system may used in the “over-the-wire” approach described herein.

[0080] In FIG. 8, there is illustrated removal of guidewire 160 while leaving balloon dilation catheter 100 in position at point proximal to blockage 15. This is an advantageous feature of the present balloon dilation catheter which is not possible with the balloon dilation catheter taught in Horzewski. Thus, guidewire 160 may simply be replaced with another guidewire by removing the original guidewire from proximal end 105 of balloon dilation catheter 100 and simply inserting a replacement guidewire (not shown) into the proximal end 105 of balloon dilation catheter 100 and through tubular member 125. Thereafter, the replacement guidewire may be navigated so that it emanates from distal end 110 of balloon dilation catheter 100. The replacement guidewire is navigated to a point distal of blockage 15.

[0081] Balloon dilation catheter 100 is then navigated over the replacement guidewire such that stent 30 is in proper position with respect to blockage 15 (FIG. 8). Once the guidewire and balloon dilation catheter 100 are in the correct position, fluid is injected into first lumen 150 thereby expanding balloon 115 and stent 30 mounted thereon. Deployment of a stent in this manner is conventional and within the purview of a person skilled in the art.

[0082] In FIGS. 10 and 11, there is illustrated rapid exchange of balloon dilation catheter 100 while leaving guidewire 160 in place. In this case, for clarity, stent 30 is not shown on balloon 115. One of the features of the present balloon dilation catheter which distinguishes it from that in Horzewski is that guidewire 160 emanates from a proximal portion of balloon dilation catheter 100 which is always outside the body of the patient. This provides the practitioner with the “over-the-wire” approach described above. Thus, either opening 130 is located outside the body at all times during use of catheter 100 illustrated in FIG. 1 or it is necessarily emanating from the proximal end of balloon dilation catheter 100 if the modified embodiment in FIG. 4 is utilized.

[0083] When it is desired to exchange balloon dilation catheter 100, the balloon dilation catheter is withdrawn from artery 20 while leaving guidewire 160 in place. As balloon dilation catheter 100 is withdrawn from the body of the patient, it may be readily separated from guidewire 160 via slit 135 along virtually the entire length of tubular member 125—this is one of the principal advantages of the present balloon dilation catheter which, to the knowledge of the present inventors, has not been achieved with a prior balloon dilation catheter. Once distal end 110 of balloon dilation catheter 100 is withdrawn from the body, balloon 115 may be exchanged from guidewire 160 in a conventional manner.

[0084] A replacement balloon dilation catheter may then be fed over guidewire 100 and navigated into artery 20 in the area of blockage 15.

[0085] With reference to FIG. 12, there is illustrated yet a further alternate embodiment to the present balloon dilation catheter. In this case, a slit 135 b is provided in balloon 115 b such that slit 135 is in communication with slit 135 b on balloon 115 b. This modification of balloon catheter 100 is particularly advantageous when the catheter is being used in an angioplasty application (i.e., without a stent mounted on balloon 115) as a pre-dilation balloon catheter allowing for enhanced rapid exchange features by facilitating withdrawal of guidewire 160 in a rapid exchange manner along virtually the entire length of tubular member 125 and balloon 115 b via the combination of slits 135 and 135 b. This feature is generally advantageous since it facilitates withdrawal of the balloon dilation catheter from the patient.

[0086] With reference to FIG. 13, there is illustrate a preferred modification to tubular member 125 of balloon catheter 100. Specifically, a third lumen 180 is provided along substantially the entire length of tubular member 125. Disposed within third lumen 180 is a stiffening member 185 which serves to improve the “torqueability” of balloon dilation catheter. Unlike, the approach in Horzewski described above wherein a single lumen does double duty for receiving: (i) a stiffening member along most of the length of the catheter and (ii) the guidewire along a minor portion of its length, the approach shown in FIG. 13 is a significant improvement over Horzewski since it maximizes both the distance over which rapid exchange may be effected and the distance over which stiffening may be conferred to the tubular member.

[0087] While this invention has been described with reference to illustrative embodiments, this description is not intended to be construed in a limiting sense. For example, while the illustrated embodiments depict use of the present balloon dilation catheter in delivery of a stent, those of skill in the art will immediately appreciate that the present balloon dilation catheter may be used in percutaneous transluminal coronary angioplasty techniques. Various modifications of the illustrative embodiments, as well as other embodiments of the invention, will be apparent to persons skilled in the art upon reference to this description. It is therefore contemplated that the appended claims will cover any such modifications or embodiments.

[0088] All publications, patents and patent applications referred to herein are incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety. 

What is claimed is:
 1. A balloon dilation catheter comprising: a tubular member having a proximal end and a distal end; an inflatable balloon disposed at the distal end of the tubular member; a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon; a second lumen disposed in the tubular member for receiving a guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.
 2. The balloon dilation catheter defined in claim 1, wherein the first slit extends from the first opening to an area on the tubular member which is proximal to the inflatable balloon.
 3. The balloon dilation catheter defined in claim 1, wherein the slit extends from the first opening to the second opening.
 4. The balloon dilation catheter defined in claim 1, wherein the inflatable balloon comprises a second slit in substantial alignment with the first slit.
 5. The balloon dilation catheter defined in claim 4, wherein at least a portion of the second slit is reinforced.
 6. The balloon dilation catheter defined in claim 1, further comprising a third lumen for receiving a stiffening member.
 7. The balloon dilation catheter defined in claim 6, further comprising the stiffening member disposed in the third lumen.
 8. The balloon dilation catheter defined in claim 6, wherein the third lumen at least partially encompasses the second lumen.
 9. The balloon dilation catheter defined in claim 7, wherein the stiffening member comprises a metal wire.
 10. The balloon dilation catheter defined in claim 1, wherein the first lumen and the second lumen each comprise a passageway having a substantially circular cross-section disposed in a substantially solid tubular member.
 11. The balloon dilation catheter defined in claim 1, further comprising at least one radioopaque marker disposed on the tubular member.
 12. The balloon dilation catheter defined in claim 1, wherein the tubular member is constructed from plastic material having various density to provide a decreasing stiffness from the proximal end to the distal end.
 13. A catheterization kit comprising: a guide catheter; a guide wire; and a balloon dilation catheter comprising: a tubular member having a proximal end and a distal end; an inflatable balloon disposed at the distal end of the tubular member; a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon; a second lumen disposed in the tubular member for receiving the guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.
 14. The catheterization kit defined in claim 13, wherein the first slit extends from the first opening to an area on the tubular member which is proximal to the inflatable balloon.
 15. The catheterization kit defined in claim 13, wherein the slit extends from the first opening to the second opening.
 16. The catheterization kit defined in claim 13, wherein the inflatable balloon comprises a second slit in substantial alignment with the first slit.
 17. The catheterization kit defined in claim 16, wherein at least a portion of the second slit is reinforced.
 18. The catheterization kit defined in claim 13, wherein the balloon dilation catheter further comprises a third lumen for receiving a stiffening member.
 19. The catheterization kit defined in claim 18, further comprising the stiffening member disposed in the third lumen.
 20. The catheterization kit defined in claim 18, wherein the third lumen at least partially encompasses the second lumen.
 21. The catheterization kit defined in claim 18, wherein the stiffening member comprises a metal wire.
 22. The catheterization kit defined in claim 13, wherein the first lumen and the second lumen each comprise a passageway having a substantially circular cross-section disposed in a substantially solid tubular member.
 23. The catheterization kit defined in claim 13, wherein the balloon dilation catheter further comprises at least one radioopaque marker disposed on the tubular member.
 24. The catheterization kit defined in claim 13, wherein the tubular member is constructed from plastic material having various density to provide a decreasing stiffness from the proximal end to the distal end.
 25. A stent-mounted balloon catheter comprising: a tubular member having a proximal end and a distal end; an inflatable balloon disposed at the distal end of the tubular member; a stent mounted on the inflatable balloon; a first lumen disposed in the tubular member and in communication with an interior of the inflatable balloon; a second lumen disposed in the tubular member for receiving a guidewire substantially along its entire length, the second lumen having a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member; and a first slit disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen.
 26. The balloon catheter defined in claim 25, wherein the first slit extends from the first opening to an area on the tubular member which is proximal to the inflatable balloon.
 27. The balloon catheter defined in claim 25, wherein the slit extends from the first opening to the second opening.
 28. The balloon catheter defined in claim 25, wherein the inflatable balloon comprises a second slit in substantial alignment with the first slit.
 29. The balloon catheter defined in claim 28, wherein at least a portion of the second slit is reinforced.
 30. The balloon catheter defined in claim 25, further comprising a third lumen for receiving a stiffening member.
 31. The balloon dilation catheter defined in claim 30, further comprising the stiffening member disposed in the third lumen.
 32. The balloon catheter defined in claim 30, wherein the third lumen at least partially encompasses the second lumen.
 33. The balloon catheter defined in claim 31, wherein the stiffening member comprises a metal wire.
 34. The balloon catheter defined in claim 25, wherein the first lumen and the second lumen each comprise a passageway having a substantially circular cross-section disposed in a substantially solid tubular member.
 35. The balloon catheter defined in claim 25, further comprising at least one radioopaque marker disposed on the tubular member.
 36. The balloon catheter defined in claim 25, wherein the tubular member is constructed from plastic material having various density to provide a decreasing stiffness from the proximal end to the distal end. 